FDA Adverse Event Injury Summary report: N

SHOCKWAVE

MDR report key: 6186423 · Received December 14, 2016

Report

Report Number
MW5066793
Event Type
Injury
Date Received
December 14, 2016
Date of Event
February 24, 2014
Report Date
December 14, 2016
Manufacturer
UNK
Product Code
NCV
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

DATE IS APPROXIMATE. SHOCKWAVE TREATMENT CAUSED ME TO MISCARRY A PREGNANCY. I WAS TREATING FOR WORK COMP INJURIES WITH (B)(6), DC AT (B)(6) CLINIC. THE CLINIC HAS SINCE BEEN CLOSED AS A PART OF A SUSPECTED WORK COMP FRAUD RING. MY COMPLAINT IS ABOUT HIS IMPROPER USE OF SHOCKWAVE ELECTROTHERAPY. THE TREATMENT WAS APPLIED TO MY SHOULDER. I WAS TOLD IT WOULD HELP ME HEAL FROM MY INJURIES. PAIN WAS DEBILITATING AND I WAS DESPERATE. NO OTHER TREATMENT MODALITIES HAD BEEN ATTEMPTED AS DESCRIBED IN THE INFORMATION WHICH THE FDA HAS ONLINE. I ONLY RECENTLY FOUND THIS INFORMATION ABOUT THIS TREATMENT. I WAS NOT AWARE I WAS PREGNANT. I HAD JUST BEEN TO A FERTILITY DOCTOR WITH MY HUSBAND AND TOLD THAT DOCTOR I WAS LATE AND THAT WE MIGHT NOT NEED HIS SERVICES. THE FERTILITY DOCTOR DID NOT OFFER A PREGNANCY TEST WHICH MY INSURANCE WOULD HAVE COVERED. THE FERTILITY DOCTOR DID NOT ADVISE ME TO BE CAREFUL. SO WHEN THIS SHOCKWAVE TREATMENT WAS OFFERED, I FELT OBLIGED TO ACCEPT IT. DR. (B)(6) DID NOT OFFER A PREGNANCY TEST. DR. (B)(6) DID NOT ASK ME IF I THOUGHT I COULD POSSIBLY BE PREGNANT OR IF I WAS EVEN LATE GETTING MY PERIOD. DR. (B)(6) DID NOT EVER OFFER ANY OTHER TREATMENT MODALITIES EXCEPT TENS AND CHIROPRACTIC MANIPULATION. NO OTHER DOCTOR AT (B)(6) CLINIC OFFERED ANY OTHER TREATMENT MODALITIES PRIOR TO THAT DATE. I AM VERY UPSET OVER THIS TO THIS DAY BECAUSE MY HUSBAND AND I WERE TRYING TO HAVE CHILDREN AND THAT WAS MY ONLY CHANCE. WE HAD BEEN TYING FOR SOME TIME WITHOUT ANY SUCCESS. I DID NOT EVEN KNOW I WAS PREGNANT UNTIL THE VERY SMALL FETUS EXPELLED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
823560 SHOCKWAVE SHOCKWAVE NCV UNK

Patients

Seq Age Sex Outcome Treatment
1 43 YR Other RX MEDS: ARMOUR THYROID